Quality Assurance Manager

Great opportunity to work at a company that specializes in the development, manufacture, and distribution of point of care analyzers for hemoglobin, glucose, lactate, chemical chemistry products, bio-marker-based ELISA and rapid tests.

Quality Assurance Manager

South Bend, IN.

80-105K DOE

Plans, coordinates, and directs quality assurance and regulatory activities to ensure continuous production of products consistent with the Quality Management System and Regulatory requirements with a focus on organizational compliance.

Ensures all products manufactured and services provided by the company meet the applicable quality and regulatory requirements.

Experience leading a team of QA personnel

Experience in Risk Management, CAPA execution, and Root Cause Analysis

Prior experience as lead for external/customer audits.

Responsible for leading Management Reviews.

Prior experience leading certification audits (TUV SUD, BSI, FDA etc.) and understanding how to respond to findings, etc.

Represent company in customer and regulatory audits.

Perform product release functions.

Assist in development of validation protocols.

Manage communications with the FDA and other regulatory bodies as needed.

Manage eQMS database.

REQUIRED QUALIFICATIONS:

Knowledge and understanding of 21CFR Part 820 – QSR, 21CFR Part 210 & 211, ISO 13485:2016, ISO14971:2012, ISO9001:2015.

Technical knowledge of in-vitro diagnostic products.

EDUCATION/EXPERIENCE

B.S. in Chemistry, Biology, or equivalent.

Minimum 5 years in QA Management.

Technical knowledge of fermentation and bioprocesses.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!